Developing Guidelines on Reporting Adverese Cosmetic Product Reaction for Notifier According to Cosmetics Act B.E.2558 (2015)

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Waelta Prapatsorn Prapatsorn

Abstract

According to Cosmetics Act B.E. 2558 (2015) the authority should set the Guidelines of Reporting on the Adverse Cosmetic Product Reaction for the notifer of cosmetics. This study aimed to conduct on the comparative study among the guidelines on reporting adverse cosmetic product reaction of the European Union (EU), ASEAN and Thailand. It was a document research and qualitative research.The ASEAN Guidelines and Forms on Reporting Adverse Cosmetic Product Reaction for the Industry was used to be the prototype for a  sub-group meeting among the staff of cosmetics Section and sub-committee meeting among  22 persons, consisting of the officials from the Food and Drug Administration, the representatives of the relevant government agencies, and private sectors. The draft of Guidelines and the Reporting Form were revised and asked the opinions the meeting of the manufacturers and importers of cosmetics. Then the comments from the meeting were used to improve the draft guidelines and reporting form for further benchmarking against the EU's,  ASEAN's  and Thailand‘s  reporting system.    The results showed that the guidelines for Thailand should include 6 sections which were Definitions, Types of Serious Adverse Cosmetic Reaction, Data collection in a Product Information File (PIF), Direction of reporting the Serious Adverse Cosmetic Reaction, Time to submit the report, and Penalty for violating the Guidelines. For the Form of collecting adverse cosmetics reaction. It was improved to be suitable for Thailand. After The guidelines issuance, the guidelines manual should be prepared for the notifiers to 1) recognize their duty, and responsibility for the Adverse Cosmetic Reaction 2) set up the surveillance program for managing the Adverse Cosmetic Reaction product sampling for analysis and data collection in a Product Information File (PIF) 3) The consumers to consult the medical professional for their Adverse Cosmetic Reaction.

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รายงานการวิจัย

References

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